technical Quality Assurance & compliance associateRoche

Job Description
The Position
Responsibilities and Accountabilities
Quality Standards, Procedures & Compliance
Handles finished product releases for distribution
Commercial releases
PTAP, FOC, PEP, DOH, CSP and Physician's Samples
Conducts annual product quality reviews of assigned products.
Participates during audit and surveillance of prospective or approved distribution centers, suppliers of packaging materials and Roche Access Program (RAP) site/s, as necessary.
Monitoring of corrective action and preventive action (CAPA) based on the audit findings.
Monitor and updates on Quality Agreements for existing suppliers, distribution centers and RAP sites
Product complaints initial assessment, recommendation and communication to patient/complainant the final investigation report.
Physical inspection of returned products, preparation and completion of reports.
Periodic review of packaging material specifications.
Recommends product or material for destruction
Creation and revision of local instructions, standard operating procedures and related forms in alignment to global updates and new processes.
Creation and revision of redressing records that affect regulatory relevant information (Work Instructions, Packaging Material Specifications and New Packaging Material Information Sheet) in Veeva Vault
Responsible for local artwork development
Handles product bidding and delivery technical document requirements
Support risk management assessment
Responsible for local training matrix maintenance, monitoring of completion, verification of personnel qualification status, and support external stakeholders training related to handling of Roche products.
Legal Affairs and Compliance
Support in documenting/reporting and monitoring the Risks & Opportunities Assessment in CARISMA
Conduct periodic Healthcare Compliance Monitoring and Reporting in coordination with RSS
Institute and Administer/Maintain Compliance Evidencing Tool
Support the Compliance Officer in reviewing and drafting updates of Healthcare Compliance Policies/SOPs/Work Instructions and Contract Templates, and maintaining these in a repository.
Review the accreditation of proper recipients of GSDs and the conduct of Due Diligence of High Risk Third Party Partners by project owners
Document/Draft Reports as may be required by the Compliance Officer based on the Prevent,
Detect, Respond Compliance Management Framework
Administrator of GRACE/MyBuy (contracts repository)
Quality Strategy
Keep cross-functional partners and stakeholders informed of key quality/regulatory activities, progress and outcomes. Include communicating any real or potential risks or other issues.
Promote quality awareness, achievement and performance improvement throughout the organization and amongst Roche customers.
Policies & Procedures
Complies with Roche Business values, policies and standard operating procedures.
Adheres to drug safety reporting obligations to ensure that Roche is compliant with regulatory obligations at all times.
Acts in accordance with company policies and procedures at all times, including Health & Safety requirements.
Teamwork/Culture
Contributes fully towards creating a productive, friendly team environment.
Fosters and participates in positive communication.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.